MODIFICATION TO FLOWSCREEN

K062011 · Viasys Healthcare GmbH · BTY · May 11, 2007 · Anesthesiology

Device Facts

• Record ID: K062011
• Device Name: MODIFICATION TO FLOWSCREEN
• Applicant: Viasys Healthcare GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry). Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance. The FlowScreen is powered from 115V/60Hz wall outlets. No energy is transferred to the patient.

Device Story

FlowScreen is a diagnostic spirometry system; records/assesses inspiratory and expiratory pulmonary function. Used in clinics, doctor's offices, or hospitals under physician direction. Operates via 115V/60Hz wall power; no energy transferred to patient. Patient performs maneuvers; device captures respiratory data; processes inputs to provide pulmonary function metrics. Healthcare providers use output to assess lung function and support clinical decision-making regarding respiratory health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diagnostic spirometry system; 115V/60Hz AC power; non-patient contacting energy transfer; intended for clinical/hospital use.

Indications for Use

Indicated for recording and assessing inspiratory and expiratory pulmonary function (spirometry) in patients aged 4 years and older capable of cooperating with test performance. Used under physician direction in clinical, office, or hospital settings.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Viasys Healthcare GmbH C/O Ms. Yvette Lloyd Viasys Respiratory Care, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887

MAY 1 1 2007

Re: K062011

Trade/Device Name: FlowScreen Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY Dated: April 12, 2007 Received: April 13, 2007

Dear Ms. Lloyd:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lloyd

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Clive S

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K062011

Device Name: FlowScreen

Indications for Use:

The FlowScreen is a diagnostic system for recording and assessing inspiratory and expiratory pulmonary function (spirometry).

Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.

The FlowScreen is powered from 115V/60Hz wall outlets. No energy is transferred to the patient.

November-16-2006 Elmar Niedermeyer (Regulatory Affairs)

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chlutto

nesthesiology, General H trol, Dental Devic

K86201

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